Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits with “Delay Until” Option and…
Medical device recall Z-1567-2014. Published in FDA’s Enforcement Report on May 21, 2014.
- FDA Class I
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on May 21, 2014. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 57,219 units total (55,756 units in US) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
CareFusion is recalling the Alaris Pump model 8100 version 9.1.18 because it may have a software issue that results in situation where the pump module will not properly delay an infusion when the “Delay Until” option or “Multidose” feature is used.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits with “Delay Until” Option and “Multidose” Feature The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural.
57,219 units total (55,756 units in US), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial no. 14031885 14031892 14031897 14031916 14032037 14032060 14032075 14032083 14032091 14032105 14032510 14032588 14032682 14032683 14032684 14032686 14032729 14032741 14032774 14032775 14035370 14035776 14035827 14035855 14035963…
Every code shown here, 2,000 characters
Serial no. 14031885 14031892 14031897 14031916 14032037 14032060 14032075 14032083 14032091 14032105 14032510 14032588 14032682 14032683 14032684 14032686 14032729 14032741 14032774 14032775 14035370 14035776 14035827 14035855 14035963 14036178 14036191 14036215 14036219 14036422 12773501 13184780 13932274 13932283 13932301 13932329 13932333 13990520 13990521 13990661 13990694 13990697 13990698 13990699 13990701 13990738 13990741 13990742 13990807 13990872 13990928 13990930 13990938 13990955 13990957 13990958 13990976 13990978 13990982 13990985 13990999 13991000 13991002 13991008 13991013 13991014 13991020 13991028 13991031 13991037 13991044 13991048 13991052 13991056 13991066 13991073 13991084 13991088 13991089 13991090 13991107 13991109 13991150 13991167 13991168 13991169 13991170 13991171 13991184 13991196 13991225 13991229 13991231 13991247 13991248 13991306 13991308 13991312 13991339 13991342 13991375 13991379 13991458 13991495 13991502 13991525 13991527 13991564 13991566 13991577 13991589 13991591 13991592 13991600 13991607 13991609 13991613 13991615 13991616 13991724 13991725 13991738 13991741 13991749 13991750 13991751 13991752 13991769 13991771 13991772 13991774 13991776 13991778 13991785 13991787 13991809 13991827 13991828 13991829 13991831 13991845 13991849 13991850 13991856 13991858 13991859 13991860 13991865 13991866 13991871 13991876 13991877 13991880 13991882 13991889 13991890 13991904 13991912 13991925 13991926 13991928 13991929 13991930 13991931 13991932 13991933 13991934 13991938 13991939 13991954 13991956 13991958 13991960 13991969 13991971 13991972 13991984 13991990 13991992 13991993 13991999 13992001 13992003 13992004 13992006 13992007 13992015 13992029 13992030 13992069 13992070 13992071 13992075 13992076 13992080 13992090 13992095 13992104 13992109 13992129 13992157 13992158 13992164 13992170 13992179 13992199 13992203 13992212 13992217 13992226 13992228 13992238 13992239 13992241 13992242 13992251 13992257 13992258 13992259 13992270 13992274…
FDA’s list runs to 564,364 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution-USA (nationwide) and the countries of Canada, AE, AU, and KW.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Apr 23, 2014.
- FDA classified it on May 14, 2014.
- FDA’s Enforcement Report published it on May 21, 2014.
- FDA terminated it on Mar 1, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- CareFusion 303, Inc., of San Diego, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 564,364 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.